Learn more about BRENZAVVY for patients.

IMPORTANT SAFETY INFORMATION

Do not take BRENZAVVY (bexagliflozin) if you:

• Are allergic to bexagliflozin or any ingredients in BRENZAVVY

BRENZAVVY can cause serious side effects, including:

Diabetic Ketoacidosis: (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. BRENZAVVY can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood.

Stop taking BRENZAVVY and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.

• nausea
• vomiting
• stomach-area (abdominal) pain
• tiredness
• trouble breathing
• ketones in your urine or blood

Amputations: BRENZAVVY may increase your risk of lower limb amputations. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation.

You may be at a higher risk of lower limb amputation if you:

• have a history of amputation
• have heart disease or are at risk for heart disease
• have had blocked or narrowed blood vessels, usually in your leg, or have damage to the nerves (neuropathy) in your leg
• have had diabetic foot ulcers or sores

Call your healthcare provider right away if you have new pain or tenderness or any sores, ulcers, or infections in your leg or foot. Your healthcare provider may decide to stop your BRENZAVVY treatment for a while if you have these signs or symptoms. Talk to your healthcare provider about proper foot care.

Dehydration: BRENZAVVY can cause some people to become dehydrated (the loss of body water and salt). Dehydration can make you feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking BRENZAVVY.

You may be at higher risk of dehydration if you:

• have low blood pressure
• take medicines that lower your blood pressure, including diuretics (water pills), or are on a low-sodium (salt) diet
• have kidney problems
• are 65 years of age or older

Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you are sick and cannot eat, or start to lose liquids from your body due to conditions like vomiting or diarrhea.

Vaginal yeast infection: Women who take BRENZAVVY may get vaginal yeast infections.

Yeast infections can be a serious but common side effect of taking BRENZAVVY. Symptoms of a vaginal yeast infection include:

• vaginal odor
• white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
• vaginal itching

Yeast infection of the penis (balanitis or balanoposthitis): Men who take BRENZAVVY may get a yeast infection of the skin around the penis. Men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis.

Other symptoms of yeast infection of the penis include:

• redness, itching, or swelling of the penis
• rash of the penis
• foul smelling discharge from the penis
• pain in the skin around penis

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider as soon as possible if you use an over-the-counter antifungal medication and your symptoms do not go away.

The most common side effects of BRENZAVVY (bexagliflozin) include:

• vaginal yeast infections
• urinary tract infection
• changes in urination including an urgent need to urinate more often, in larger amounts, or at night.

Before you take BRENZAVVY, tell your healthcare provider about all of your medical conditions, including if you:

• have type 1 diabetes or have had diabetic ketoacidosis
• have a decrease in your insulin dose
• have a serious infection
• have a history of infection of the vagina or penis
• have a history of amputation
• have had blocked or narrowed blood vessels, usually in your leg
• have damage to the nerves (neuropathy) in your leg
• have had diabetic foot ulcers or sores
• have kidney problems
• have liver problems
• have a history of urinary tract infections or problems with urination
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
• are on a low sodium (salt) diet. Your healthcare provider may change your diet or your dose.
• are going to have surgery. Your healthcare provider may stop your BRENZAVVY before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking BRENZAVVY and when to start it again.
• are eating less or there is a change in your diet
• are dehydrated
• drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
• have ever had an allergic reaction to BRENZAVVY
• are pregnant or planning to become pregnant. BRENZAVVY may harm your unborn baby. If you become pregnant while taking BRENZAVVY, tell your healthcare provider as soon as possible. Talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
• are breastfeeding or plan to breastfeed. BRENZAVVY may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take BRENZAVVY. Do not breastfeed while taking BRENZAVVY.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

BRENZAVVY may affect the way other medicines work, and other medicines may affect how BRENZAVVY works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of BRENZAVVY?

Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking BRENZAVVY. Tell your healthcare provider if you have signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.

Low blood sugar (hypoglycemia). If you take BRENZAVVY with another medicine that can cause low blood sugar such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take BRENZAVVY. Signs or symptoms of low blood sugar may include:

• headache
• confusion
• hunger
• shaking or feeling jittery
• drowsiness
• dizziness
• fast heartbeat
• weakness
• sweating
• irritability

A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in people who take BRENZAVVY. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals:

• pain or tenderness
• swelling
• redness of the skin (erythema)

Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking BRENZAVVY and call your healthcare provider right away or go to the nearest hospital emergency room. Symptoms of a serious allergic reaction to BRENZAVVY may include:

• skin rash
• raised red patches on your skin (hives)
• swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

You are encouraged to report side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional important safety information about BRENZAVVY, please see the Medication Guide.